A Study Of The Safety And Efficacy Of Levetiracetam (Keppra®) (Ucb L059) In Children With Epilepsy - Full Text View

Sponsored by:	UCB
Information provided by:	UCB
ClinicalTrials.gov Identifier:	NCT00150709

Purpose

The open-label study to allow pediatric patients who have participated in prior Levetiracetam (Keppra®) studies to continue their treatment with adequate monitoring and standardized follow-up care until Levetiracetam (Keppra®) is approved for use in children or until the completion of the development program for pediatrics.

Condition	Intervention	Phase
Epilepsy, Partial	Drug: Levetiracetam (Keppra)	Phase III

Genetics Home Reference related topics: autosomal dominant partial epilepsy with auditory features pyridoxal 5'-phosphate-dependent epilepsy

MedlinePlus related topics: Epilepsy

Drug Information available for: Levetiracetam

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title:	A Multi-Center, Open-Label, Long-Term, Follow-Up Study Of The Safety And Efficacy Of Levetiracetam (Ucb L059) In Children With Epilepsy

Further study details as provided by UCB:

Primary Outcome Measures:

To allow pediatric patients who have participated in a previous trials the opportunity to receive open-label levetiracetam (Keppra) treatment.
Efficacy measured by weekly seizure frequency.

Secondary Outcome Measures:

To obtain standardized descriptive safety and efficacy data in pediatric epileptic patients

Estimated Enrollment:	238
Study Start Date:	February 1998
Study Completion Date:	January 2006
Primary Completion Date:	January 2006 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	up to 16 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Have completed Study N151, or any other applicable pediatric trials of Levetiracetam (Keppra®)
Be a patient for whom the treatment of Levetiracetam (Keppra®) would be of potential benefit such that the patient/parent(s)/legal guardian and the Investigator agree to continue treatment.

Exclusion Criteria:

Not be on a ketogenic diet (during the course of this study).
Not have seizures too close together to accurately count (i.e., the patient's seizures must be countable).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00150709

Sponsors and Collaborators

UCB

Investigators

Study Director:

Françoise Tonner, MD

UCB

More Information

Study ID Numbers:	N157
Study First Received:	September 6, 2005
Last Updated:	March 7, 2008
ClinicalTrials.gov Identifier:	NCT00150709
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada; Mexico: Ministry of Health

Keywords provided by UCB:

Epilepsy, Pediatric , partial onset epilepsy,
Levetiracetam (Keppra®)

Study placed in the following topic categories:

Epilepsies, Partial
Epilepsy
Piracetam

Central Nervous System Diseases
Etiracetam
Brain Diseases

Additional relevant MeSH terms:

Nootropic Agents
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases
Protective Agents

Neuroprotective Agents
Central Nervous System Agents
Pharmacologic Actions
Anticonvulsants

ClinicalTrials.gov processed this record on January 16, 2009